Medication info

Ketomin Injection (Ketorolac Tromethamine)

Prescription medicationInjectionsIntramuscular injection · Intravenous injection
Ingredient · strength
Ketorolac Tromethamine›30mg / 1mL
Manufacturer / importer
Ilyun Pharmaceutical Co., Ltd.
Appearance
A brown ampoule injection containing a pale yellow transparent liquid.
Packaging
1mL/ampoule x 50
Approval status
Active

MFDS item code 201500216 · Notified 2015.01.15 · Insurance code 658603171

Summary

Main use
Short-term relief of moderate to severe acute pain and postoperative pain in children for whom opioid analgesics are contraindicated
Who receives it
Adults · Children
Adult administration
○ Adults: For intramuscular or intravenous administration, administer an initial dose of 10 mg ketorolac tromethamine, followed by a maintenance dose of 10∼30 mg every 4∼6 hours. Use the lowest effective dose. Do not administer for more than 2 days. The daily dose should not exceed 90 mg (60 mg for older adults, patients with renal impairment, and patients weighing 50 kg or less). Do not administer epidurally or intrathecally. The dose or dosing interval may be adjusted according to symptoms and the severity of pain. Opioids may be administered concomitantly as needed.
Child administration
○ Children 2 years of age and older: Administer as a single intravenous dose after surgery in children. Thereafter, several intravenous bolus doses may be given as needed. Intravenous administration is recommended for children because intramuscular injection is painful. Administer a single dose of 0.5∼1.0 mg/kg, followed, if needed, by 0.5 mg/kg every 6 hours. Do not administer for more than 2 days. The dose or dosing interval may be adjusted according to symptoms and the severity of pain.

Ingredients

Manufacturer
Ilyun Pharmaceutical Co., Ltd.

Efficacy & effects

Short-term relief of moderate to severe acute pain and postoperative pain in children for whom opioid analgesics are contraindicated

  • Acute pain
  • postoperative pain
View approved original text

This medication is used for the short-term relief of acute pain ranging from moderate to severe, particularly postoperative pain. It is also effective for the treatment of severe postoperative pain in children aged 2 years and older when opioid analgesics cannot be used. Therefore, it is utilized as a safe and reliable option for postoperative pain management.

How it is given

Adult administration

○ Adults: For intramuscular or intravenous administration, administer an initial dose of 10 mg ketorolac tromethamine, followed by a maintenance dose of 10∼30 mg every 4∼6 hours. Use the lowest effective dose. Do not administer for more than 2 days. The daily dose should not exceed 90 mg (60 mg for older adults, patients with renal impairment, and patients weighing 50 kg or less). Do not administer epidurally or intrathecally. The dose or dosing interval may be adjusted according to symptoms and the severity of pain. Opioids may be administered concomitantly as needed.

Child administration

○ Children 2 years of age and older: Administer as a single intravenous dose after surgery in children. Thereafter, several intravenous bolus doses may be given as needed. Intravenous administration is recommended for children because intramuscular injection is painful. Administer a single dose of 0.5∼1.0 mg/kg, followed, if needed, by 0.5 mg/kg every 6 hours. Do not administer for more than 2 days. The dose or dosing interval may be adjusted according to symptoms and the severity of pain.

Precautions

This medication is a non-steroidal anti-inflammatory analgesic with antipyretic and analgesic effects. Before taking this medication, individuals who regularly consume alcohol should consult a doctor or pharmacist, as taking it with alcohol may increase the risk of gastrointestinal bleeding. This medication may pose risks to the cardiovascular system. Serious thrombotic events such as myocardial infarction or stroke may occur, so caution is advised, especially for patients with cardiovascular diseases or risk factors. In patients with coagulopathy or those taking anticoagulants such as warfarin or heparin, the risk of bleeding may be increased, requiring careful monitoring. This medication can also impact the gastrointestinal tract, posing risks of gastrointestinal bleeding, ulcers, and perforations, which necessitate increased caution in elderly or frail patients. Patients with impaired kidney function or kidney diseases should be cautious, as there is a risk of kidney damage when taking this medication. Allergic reactions such as anaphylaxis, skin rashes, and bronchospasms can occur, especially in patients who have previously had hypersensitivity reactions to aspirin or other non-steroidal anti-inflammatory drugs. Women who are pregnant or planning to become pregnant are advised against using this medication, as it may impair fertility. Taking it in conjunction with other non-steroidal anti-inflammatory medications may increase the risk of adverse reactions and is therefore not recommended. Care should be taken when using ampoule injections, as there is a risk of glass fragment contamination, with heightened caution needed for children and the elderly. This medication should not be administered to patients with gastrointestinal ulcers, bleeding disorders, blood diseases, cardiovascular diseases, kidney diseases, asthma, or allergic reactions, nor to patients at high risk for postoperative bleeding. Elderly patients or those with liver impairment, kidney impairment, hypertension, heart failure, or dehydration should be administered this medication with caution. During treatment with this medication, a variety of side effects such as nausea, dyspepsia, abdominal pain, diarrhea, rash, headache, dizziness, liver function abnormalities, and renal function abnormalities may occur, necessitating prompt consultation with healthcare professionals if abnormal symptoms arise. This medication may elevate blood pressure or exacerbate existing hypertension, so regular blood pressure monitoring is advised, along with caution for fluid retention or signs of heart failure. Long-term usage may involve the risk of kidney damage, thus regular monitoring is particularly important for patients with impaired renal function. This medication can cause severe allergic reactions such as anaphylaxis, so patients with a history of allergy to non-steroidal anti-inflammatory drugs should avoid using it. Pregnant and breastfeeding women should not take this medication, especially in the later stages of pregnancy, as it may pose risks to the fetus. The safety and efficacy of this medication have not been established in children and adolescents, so it is best not to use it in these populations. Overdosage may result in symptoms such as nausea, vomiting, and gastrointestinal bleeding, so prescribed dosages and duration should be strictly followed. This medication has many drug interactions, so patients should inform their healthcare provider of any concurrent medications, particularly anticoagulants, diuretics, lithium, methotrexate, and ACE inhibitors, as caution is warranted in such cases. Patients engaging in driving or operating machinery should be aware of potential side effects such as dizziness and drowsiness and exercise caution accordingly. This medication should be used at the lowest effective dose for the shortest duration possible. If any abnormal symptoms arise during use, treatment should be stopped immediately, and medical advice should be sought.

Side effects

Gastrointestinal bleeding, cardiovascular thrombosis reaction, myocardial infarction, stroke, bleeding, postoperative hematoma, wound bleeding, nausea, dyspepsia, gastrointestinal pain, diarrhea, constipation, abdominal distension, vomiting, stomatitis, peptic ulcer, gastrointestinal hemorrhage, perforation, bloody stool, rectal bleeding, gastritis, belching, loss of appetite, increased appetite, pancreatitis, hematemesis, esophagitis, melena, dry mouth, colitis, exacerbation of Crohn's disease, edema, anaphylaxis, bronchospasm, laryngeal edema, tongue swelling, hypotension, flushing, rash, weight gain, fever, infection, asthenia, hypertension, erythema, palpitations, pallor, syncope, bradycardia, chest pain, heart failure, erythema, pruritus, toxic epidermal necrolysis, eosinophilia, systemic symptoms accompanying drug reactions, Stevens-Johnson syndrome, exfoliative dermatitis, papular erythema, urticaria, angioedema, sweating, purpura, surgical site bleeding, thrombocytopenia, nosebleed, anemia, leukopenia, eosinophilia, hematoma, headache, sweating, drowsiness, dizziness, convulsion, tremor, hallucination, abnormal dreams, dissociative feelings, extrapyramidal syndrome, sensory disturbances, depression, insomnia, irritability, thirst, severe thirst, abnormal thoughts, concentration disturbance, hyperactivity, confusion, myalgia, aseptic meningitis, anxiety, psychotic reactions, hepatitis, liver failure, cholestatic jaundice, abnormal liver function test results, dyspnea, asthma, pulmonary edema, rhinitis, cough, acute kidney failure, flank pain, hematuria, hypernitrogenemia, oliguria, nephritis, polyuria, frequency of urination, urinary retention, hemolytic uremic syndrome, hyperkalemia, hyponatremia, nephrotic syndrome, elevated serum urea and creatinine levels, injection site pain, taste disturbance, visual disturbance, blurred vision, optic neuritis, tinnitus, hearing loss, female infertility, prolonged bleeding time

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is sensitive to light and should be stored in a light-resistant and tightly sealed container. It is essential to maintain storage temperatures between 1 and 30 degrees Celsius. Proper storage will help preserve the medication's efficacy and safety.

Appearance and packaging

Appearance

A brown ampoule injection containing a pale yellow transparent liquid.

Package unit

1mL/ampoule x 50

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Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.